Universal Diagnostics

Laboratory Program Manager

Dallas, TX, US

Remote
Full-time
about 1 month ago
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Summary

The Opportunity: Universal DX is seeking an experienced program manager to join our growing team. You will report to the Director, Program Management and work closely with the laboratory operations team to support our Dallas-based laboratory. You will interact with our quality assurance, compliance, and IT teams to support the laboratory, as well as work closely with our IVD product development team to support the necessary projects and studies conducted in the laboratory. You will play a critical part in the laboratory readiness and product development workstreams that will support the design and development of Universal DX's screening test for colorectal cancer. As the program manager, you will: * Strategize, implement, and maintain program initiatives to achieve organizational goals related to laboratory readiness and support the development and commercialization of new IVD products. * Work closely with team leads, cross-functional teams, and assigned PMs to develop the scope, deliverables, required resources, work plan, budget, and timing for existing and new initiatives. * Track execution and project team's accountability for delivering against established timelines and objectives. * Analyze, evaluate, and escalate program risks and provide program reports for management and stakeholders * Work with other program managers to coordinate cross-functional activities, identify risks and opportunities across multiple projects within the company. What you will bring: * Bachelor's degree, ideally in a scientific field (e.g., Biology, Chemistry, Biotechnology, or a related discipline) with 4-6 years of project management and/or program management experience. Experience with IVD development preferred. * Prior experience with project management tools and methods, previous experience using Smartsheet and MS office a plus. * Experience with regulated environments (CLIA, CAP, GMP) and familiarity with medical device regulatory requirements (e.g. 21CFR812, ISO 13485, etc.) * Strong organizational, problem-solving, and multitasking skills, with the ability to manage multiple priorities in a fast-paced setting. * Excellent communication and teamwork skills with the ability to facilitate and collaborate across departments effectively. * Ability to organize teams working remote in different time zones. What we´ll offer: * Flexible work schedule * Relocation assistance * Accrued time off * Company-sponsored benefit plans which include Paid Time Off, Medical, Dental, Vision, 401(k) * Free day on your birthday * And more to come…

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